Welcome to our dedicated page for Regeneron Pharmaceuticals news (Ticker: REGN), a resource for investors and traders seeking the latest updates and insights on Regeneron Pharmaceuticals stock.
Regeneron Pharmaceuticals (NASDAQ: REGN) is a leading biotechnology innovator developing transformative treatments for serious diseases through advanced platforms like VelociSuite®. This page serves as the definitive source for official company announcements, research milestones, and therapeutic developments.
Investors and medical professionals will find curated updates including FDA approvals, clinical trial results, partnership announcements, and financial reports. Our aggregation ensures timely access to Regeneron's progress in oncology, immunology, rare diseases, and ophthalmic therapies.
All content is sourced directly from Regeneron's communications and verified financial disclosures. Bookmark this page to monitor the company's pipeline advancements, regulatory updates, and strategic collaborations that drive biopharmaceutical innovation.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi presented positive results from the pivotal ADEPT Phase 2/3 trial for Dupixent® (dupilumab) in treating moderate-to-severe bullous pemphigoid (BP). The trial, involving 106 adults, demonstrated significant advantages over placebo:
Key findings at 36 weeks showed:
- 20% achieved sustained disease remission vs 4% for placebo
- 40% achieved ≥90% reduction in disease severity vs 10%
- 40% experienced meaningful itch reduction vs 11%
- 1,678mg reduction in corticosteroid exposure and 54% lower risk of rescue medication use
The FDA has accepted Priority Review for Dupixent in BP treatment, with a decision expected by June 20, 2025. The drug received Orphan Drug Designation for BP, which affects fewer than 200,000 people in the U.S. Regulatory submissions are also under review in the European Union.
Regeneron Pharmaceuticals (NASDAQ: REGN) has received a positive recommendation from the European Medicines Agency's CHMP for conditional marketing authorization of linvoseltamab, a treatment for relapsed and refractory multiple myeloma. The recommendation applies to adult patients who have undergone at least three prior therapies and shown disease progression on their last treatment.
The recommendation is based on data from the LINKER-MM1 trial. Additionally, the FDA has accepted the Biologics License Application for linvoseltamab review, with a target decision date of July 10, 2025. The European Commission's final decision is expected in the coming months. The drug remains investigational and awaits regulatory approval.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for odronextamab in treating relapsed/refractory follicular lymphoma. The FDA decision is expected by July 30, 2025.
The resubmission follows meeting the FDA-mandated enrollment target for the Phase 3 OLYMPIA-1 confirmatory trial. Phase 1 and 2 trials showed promising results with an 80% overall response rate (n=103) and 74% complete response rate (n=95). However, serious adverse events occurred in 67% of patients, including cytokine release syndrome, COVID-19, and pneumonia.
The drug is already approved as Ordspono™ in the European Union for treating relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Regeneron Pharmaceuticals (NASDAQ: REGN) reported promising results from the Phase 1/2 CHORD trial of DB-OTO, a gene therapy for profound genetic hearing loss caused by otoferlin gene variants. Of 12 treated children, 10 out of 11 with post-treatment assessments showed notable hearing improvements.
The first child treated, at 10 months old, showed near-normal hearing levels across key speech frequencies at 48 weeks, with continued progress at 72 weeks, including the ability to identify words at conversational levels. Among five participants with 24-week assessments, three achieved 'nearly normal' or normal hearing levels.
The treatment was well-tolerated across all participants, with only temporary post-surgical vestibular effects in five patients that resolved within 6 days. DB-OTO has received multiple FDA designations including Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy, as well as EMA Orphan Drug Designation.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced its participation in two major healthcare investor conferences in March 2025. The company will present at the TD Cowen 45th Annual Health Care Conference on March 4 at 11:50 a.m. ET, and the Leerink Partners 2025 Global Healthcare Conference on March 11 at 8:00 a.m. ET.
Both presentations will be accessible via webcast through Regeneron's investor relations website. The company will maintain archives of the webcasts and transcripts for a minimum of 30 days on their corporate website's 'Investors & Media' section.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for linvoseltamab, targeting the treatment of adult patients with relapsed/refractory multiple myeloma. The treatment is specifically for patients who have undergone at least four prior therapy lines or those with three prior lines who are refractory to their last treatment.
The FDA's decision is expected by July 10, 2025. The resubmission follows the resolution of third-party fill/finish manufacturing issues, which was previously the only approvability concern. The application is supported by data from the LINKER-MM1 trial and is currently also under review by the European Medicines Agency (EMA) for the same patient population.
Regeneron Pharmaceuticals (REGN) presented positive Phase 3 QUASAR trial results for EYLEA HD® (aflibercept) Injection 8 mg in treating macular edema following retinal vein occlusion (RVO). The trial met its primary endpoint, demonstrating that EYLEA HD patients dosed every 8 weeks achieved non-inferior vision gains compared to EYLEA® 2 mg dosed every 4 weeks.
Key findings show that 88% of patients maintained an 8-week dosing schedule after 3 initial monthly doses, and 93% after 5 initial monthly doses. The safety profile remained consistent with previous trials, with ocular pressure increase reported in 5% of patients. The data will support a supplemental Biologics License Application to the FDA in Q1 2025.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive three-year results for EYLEA HD® (aflibercept) Injection 8 mg in wet age-related macular degeneration (wAMD) patients from the Phase 3 PULSAR trial extension study.
Key findings after three years of EYLEA HD treatment show that 77% of patients achieved dosing intervals of ≥3 months, 58% ≥4 months, 40% ≥5 months, and 24% achieved 6-month intervals, while maintaining vision and anatomic improvements. Patients who switched from EYLEA® 2 mg to EYLEA HD also maintained improvements with extended dosing intervals: 79% achieved ≥3 months and 43% achieved ≥4 months intervals.
The safety profile remained consistent with previous trials, with ocular treatment emergent adverse events including cataract, retinal hemorrhage, and reduced visual acuity. The intraocular inflammation rate was 2.4% for patients switching from EYLEA to EYLEA HD and 1.9% for patients starting with EYLEA HD.
Regeneron (REGN) reported strong Q4 2024 financial results with revenues increasing 10% to $3.79 billion and full-year 2024 revenues up 8% to $14.20 billion. Key highlights include:
- Dupixent global net sales grew 15% to $3.70 billion in Q4 and 22% to $14.15 billion for full year
- Combined EYLEA HD and EYLEA U.S. net sales increased 2% to $1.50 billion in Q4
- Libtayo global net sales rose 50% to $367 million in Q4
The company announced significant shareholder returns including:
- Initiation of $0.88 quarterly dividend program
- Additional $3.0 billion share repurchase authorization, bringing total capacity to ~$4.5 billion
Regulatory submissions were made for EYLEA HD pre-filled syringe, Dupixent in bullous pemphigoid, and other key products. Positive Phase 3 results were reported for EYLEA HD in retinal vein occlusion and Libtayo in high-risk adjuvant cutaneous squamous cell carcinoma.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science have announced the top 40 finalists for the 2025 Regeneron Science Talent Search (STS), America's oldest and most prestigious STEM competition for high school seniors. The competition, now in its 84th year, will award over $1.8 million in prizes, with individual awards ranging from $25,000 to $250,000.
The finalists, selected from 300 scholars and nearly 2,500 total entrants, represent 39 schools across 16 U.S. states. Their research projects cover diverse topics including species migration, crop protection, disease diagnosis using AI, and genetic and cancer therapies. The competition will take place from March 6-12, 2025, in Washington D.C., with the top 10 winners being announced on March 11.
The program's alumni have achieved remarkable success, including 13 Nobel Prizes and 23 MacArthur Fellowships. Each finalist's school receives $2,000 to support math and science programs, demonstrating the competition's commitment to fostering scientific innovation and education.
